The Food and Drug Administration (FDA) said that the coronavirus test touted by President Donald Trump’s administration may provide false results.
The Abbott ID NOW point-of-care test, according to FDA, may present false negatives in some cases where patients have COVID-19. FDA granted the rapid coronavirus test emergency authorization in March.
However, the agency noted mentioned receiving 15 reports revealing that the device did not produce results with high accuracy.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Tim Stenzel, director of the FDA’s office of in vitro diagnostics, said in a statement.
“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test.”
FDA stressed it was expressing its concerns to the public “in the spirit of transparency,” clarifying that “no diagnostic test will be 100% accurate.”
The coronavirus pandemic already infected more than 1.4 million people in the US and killed more than 85,000.
On Thursday, the FDA said that any patient that tested positive for coronavirus, had negative results but had ongoing COVID-19 symptoms should undergo another test to confirm the previous results.
The White House uses the Abbott device to screen staff members and visitors and can lead to rapid results. Trump himself presented the machine during a news conference. He said that the results are “highly accurate.”
He added that the device gave the fight against COVID-19 a “whole new ballgame.”
However, two White House aides have tested positive for the coronavirus, an aide to Vice President Mike Pence and a valet to the president.
Reuters reported that Abbott Laboratories has already produced more than 1.8 million ID NOW tests throughout the US.
Abbott device efficacy
A preliminary study suggested potential problems on the efficacy of the Abbott device. According to a team of researchers from New York University, the rapid coronavirus test missed between a third to nearly half of positive cases caught on a competing device. However, the study is yet to undergo peer review.
Abbott dismissed those findings and sought to calm investors on Thursday evening.
“It’s unclear if the samples were tested correctly in this study,” the company told The Washington Post in a statement. “This rate has been previously shared with the FDA. In communications with the users of the test, it is performing as expected.”
The US government has received criticism for its handling of the coronavirus outbreak.
For example, Melinda Gates describes US coronavirus response as “chaos.” She gave it a grade of D-minus and said that the US “wasted so much time.”
“I’m surprised we’ve wasted so much time. That we haven’t had leadership at the national level to get out tests in the right way, protective gear in the right way, contact tracing in the right way… And so you’re seeing what’s happening. And it’s chaos,” she said in an interview with NBC’s “Today.”